Liquid Biopsy for Hepatocellular Carcinoma Molecular Characterization After Y90

Liquid Biopsy for Hepatocellular Carcinoma Molecular Characterization and Assessment of Treatment Response After Y90 Radioembolization: A Pilot Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07303712

Enrollment

Registered

2025-12-26

Start date

2024-08-01

Completion date

2026-12-01

Last updated

2025-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma (HCC)

Keywords

Circulating tumor cell (CTC), y90

Brief summary

The purpose of this study is to determine if baseline liquid biopsy assays (CTC and cf-DNA) as well as single circulating tumor cell-DNA (sCTC DNA) dynamics in the early post-treatment period can predict subsequent treatment response to Y-90 radioembolization in patients with hepatocellular carcinoma (HCC).

Detailed description

Study Aims and Objectives: 1. Assess the detection rate of CTC and cfDNA-based mutations and the distribution of molecular features of HCC prior to Y90 across BCLC A-C stages. 2. Determine CTC and cfDNA predictors at baseline that predict Y90 treatment response at 6-9 months. 3. Determine temporal changes in CTC and cfDNA mutations from baseline over 6-9 month course post Y90. 4. Determine if CTC mean distribution, sCTCDNA, and/or cfDNA mutational dynamic changes are predictive of treatment response at 6-9 months. 5. Assess radiomic and liquid biopsy signatures associated with outcome 6. Compare predictive outcome models using liquid biopsy data, imaging data, or a combination (multiomic data)

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age \> or = 18 years 2. HCC confirmed on imaging, BCLC stage 0, A, B, or C 3. Transarterial Y90 radioembolization approved by multidisciplinary tumor board -

Exclusion criteria

1. Not eligible for Y90 procedure 2. Prior surgery or ablation on indicated tumors 3. Patient unable to complete the follow up visits required for clinical care or research -

Design outcomes

Primary

Measure	Time frame	Description
Circulating Tumor Cell (CTC)	Baseline, 1 month post treatment, 3 months post treatment, and 6 months post treatment	blood samples
CTA imaging	Baseline, 3 months post treatment, 6 months post treatment	imaging of liver tumor

Countries

United States

Contacts

Primary ContactSirish Kishore, MD

sirish.kishore@va.gov650-493-5000

Backup ContactLuisa Manfredi, MPH

luisa.manfredi1@va.gov650-493-5000

Outcome results